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Related Experiment Videos

Mixing behavior of colyophilized binary systems

S L Shamblin1, L S Taylor, G Zografi

  • 1School of Pharmacy, University of Wisconsin-Madison, 425 North Charter Street, Madison, Wisconsin 53706, USA.

Journal of Pharmaceutical Sciences
|June 11, 1998
PubMed
Summary
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This study explored mixing amorphous sucrose with common pharmaceutical excipients. Results show non-ideal mixing and molecular interactions, particularly hydrogen bonding, influencing the glass transition temperature of freeze-dried preparations.

Area of Science:

  • Materials Science
  • Physical Chemistry
  • Pharmaceutical Sciences

Background:

  • Amorphous solid dispersions are crucial for enhancing drug solubility and bioavailability.
  • Understanding component interactions in multicomponent systems is vital for stable pharmaceutical formulations.
  • Freeze-drying (lyophilization) is a common technique for producing amorphous pharmaceutical preparations.

Purpose of the Study:

  • To investigate factors governing the mixing of amorphous sucrose with model excipients: trehalose, poly(vinylpyrrolidone) (PVP), dextran, and poly(vinylpyrrolidone-co-vinyl acetate) (PVP/VA).
  • To assess the impact of these interactions on the thermal properties and physical state of multicomponent freeze-dried pharmaceutical preparations.

Main Methods:

  • Mixture preparation via co-lyophilization from aqueous solutions.

Related Experiment Videos

  • Differential scanning calorimetry (DSC) for measuring glass transition temperatures (Tg).
  • FT-Raman spectroscopy to detect molecular interactions.
  • X-ray powder diffraction for confirming amorphous state.

    • Main Results:

    • Colyophilized mixtures were confirmed to be amorphous.
    • Measured Tg values were generally lower than predicted by ideal mixing models, indicating non-ideal mixing.
    • FT-Raman spectroscopy provided evidence of hydrogen bonding between sucrose and PVP/PVP/VA, at the expense of intra-component hydrogen bonds.
    • Thermodynamic analysis revealed endothermic mixing and a positive excess entropy, despite a positive excess free energy.

    Conclusions:

    • Mixing of amorphous sucrose with the studied excipients is non-ideal, driven by molecular interactions like hydrogen bonding.
    • The observed deviations in Tg and thermodynamic properties are consistent with a net loss of hydrogen bonding upon mixing.
    • These findings are critical for designing stable and effective amorphous solid dispersions in pharmaceutical formulations.